Centocor Inc. on Tuesday announced that its Centoxin drug tocombat sepsis and septic shock has been given its firstmarketing approval.

The Netherlands granted approval for sale of Centoxin tohospitals for treatment of patients with gram-negative sepsis.Centocor anticipates that it will receive approval in Germanynext, followed by other European Community countries.

Centoxin has not yet been scheduled for review by the Foodand Drug Administration, although there have been rumors onWall Street that the drug, along with Xoma's competing E5product, will be reviewed in July.

Gram-negative sepsis can lead to septic shock, which is markedby heart, liver and respiratory failure, and severe internalbleeding. The condition is caused when bacteria normallypresent in the gut are spilled into the body by surgery orinjury. Up to 75 percent of patients die with conventionaltreatment.

Centoxin is a monoclonal antibody derived from a human B cell.The company said it is the first human monoclonal to receivemarketing approval.

Largely in anticipation of European marketing approval,Centocor increased its spending by $15.8 million for its firstquarter ended March 31 compared with the same quarter in1990, said spokesman Charles Cabot III.

For the quarter, the Malvern, Pa., company lost $18.1 million,or $1.20 a share, on revenues of $14.7 million, compared withnet income of $17,000 on revenues of $16.7 million for the1990 quarter.

In addition to increased spending for production and salesforce development, the net loss was caused by reducedrevenues from research and development of $5.1 million,compared with $8.7 million last year. "R&D income throughpartnerships and Tocor contracts is for the most partexhausted," said Cabot. Tocor is a shell company created byCentocor in 1989.

Product sales increased to $9.6 million, compared with $8million in 1990.

Centocor stock (NASDAQ:CNTO) closed at $63.25 on Tuesday,down 63 cents. The stock has fallen $4.63 since May 2.

-- Karen Bernstein BioWorld Staff

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